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10/30208681 DC : DRAFT SEP 2010

Current

Current

The latest, up-to-date edition.

BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES

Published date

23-11-2012

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BS ISO/IEC GUIDE 63

Committee
CH/210/4
DocumentType
Draft
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/IEC Guide 63:2012 Identical

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/IEC Guide 51:2014 Safety aspects — Guidelines for their inclusion in standards
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices

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